Unclassified - Princeton, NJ
posted 2 months ago
The Clinical Trials Specialist plays a crucial role in supporting Clinical Study Leads in the execution of global clinical trials. This position encompasses a variety of responsibilities that are essential for the successful management of both internally sourced studies and those outsourced to Contract Research Organizations (CROs). The Specialist is tasked with scheduling and coordinating meetings, which includes preparing agendas, presentation materials, and minutes for clinical study team meetings. This organizational aspect is vital for ensuring that all team members are aligned and informed throughout the trial process. In addition to meeting coordination, the Clinical Trials Specialist is responsible for collating data for feasibility assessments and site selection. This involves reviewing site usability databases and contributing to the review of critical study documents such as informed consent forms and case report forms. The Specialist will also compile and maintain study manuals, manage the electronic Trial Master File (eTMF), and track site activation, enrollment, and monitoring visits. It is imperative for the Specialist to escalate any issues or delays that may arise during these processes to ensure timely resolution. The role further includes monitoring investigator and site status, supporting clinical trial registry postings, and contributing to Blind Data Review Meetings. The Specialist will also manage Third Party Vendors and participate in Standard Operating Procedure (SOP) revisions or departmental initiatives. This multifaceted position requires a blend of technical knowledge and soft skills, including strong organizational abilities, attention to detail, effective communication skills, and the capacity to manage multiple tasks simultaneously.